Amputation Clinical Trial
Official title:
Low Cost Prosthetic Socket for Lower Limb Amputees
The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries. To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | Inclusion Criteria: - Unilateral transtibial amputees having had their amputation at least 6 months prior, so that they have a relatively stable conical residual limb shape and can ambulate independently - Currently has a well-fitting prosthesis- as defined by a self-reported Socket Comfort Score of at least a 6 out of 10 - K2, K3, K4 level ambulators - Understands the English language Exclusion Criteria: - Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback and informal discussion adds significant value to this study. - Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study (e.g stroke, pacemaker placement, etc), or that would otherwise prevent acquisition of usable data by researchers. - Bulbous residual limb shape causing inability to fit within system restrictions - Open wounds on the residual limb - Inability to understand the English language |
Country | Name | City | State |
---|---|---|---|
United States | Shirley Ryan AbilityLab | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Shirley Ryan AbilityLab |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Socket Comfort Score with Experimental Low Cost Socket | The Socket Comfort Score will be used with the experimental low cost socket. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures | Day 2 | |
Primary | Socket Comfort Score with Clinically Prescribed Socket | The Socket Comfort Score will be used with the subjects clinically prescribed prosthetic system. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures | Day 2 | |
Secondary | Four Square Step Test | A clinical test of the ability to change directions while stepping. | Day 2 | |
Secondary | L-Test of Functional Mobility | The L Test is a timed ambulation over 20 meters, which includes two sit to/from stand transfers and three turns. | Day 2 | |
Secondary | 2 Minute Walk Test | Individual walks without assistance for 2 minutes and the distance is measured. | Day 2 | |
Secondary | Amputee Mobility Predictor | A questionnaire that measures the ambulatory potential of lower limb amputees. It requires the amputee to complete various tasks. Including sitting balance, reaching, transfers, sit to stand, and standing balance, | Day 2 |
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